HPTN 073 Black Men Who Have Sex With Men (MSM) Pre-Exposure Prophylaxis (PrEP)

NCT01808352 | Completed DMC FDA Drug

• 1 other identifier: HPTN 073
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 3

Brief Summary

Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client Centered Care Coordination (C4) Component.

Conditions

HIV

Keywords

AE adverse event; AIDS acquired immunodeficiency syndrome; ALT (SGPT) alanine aminotransferase; ART antiretroviral therapy; AST (SGOT) aspartate aminotransferase; DCF data collection forms; DMC Data Monitoring Committee; FDA (U.S.) Food and Drug Administration; GCP Good Clinical Practice guidelines; HB sAg Hepatitis B surface antigen; ICH International Conference of Harmonisation; IND Investigational New Drug Application; IRB Institutional Review Board; IU International units; mg milligram(s); mm3 cubic millimeter(s); PCR polymerase chain reaction; SAE serious adverse event; µg microgram; ULN upper limit of the normal range; WB Western Blot

Outcome Measures

Primary Outcomes (2)

• Initiation of PrEP

  Documented in either study CRFs or ACASI

  30 months

• Adherence to PrEP

  Adherence will be assessed via self-report (ACASI), PBMCs and plasma concentration

  30 months

Secondary Outcomes (6)

• Adverse events

  30 months

• STIs

  30 months

• Changes in sexual risk-taking behavior

  30 months

• Initiate or decline PrEP

  30 months

• Incident HIV-seroconversions/characteristics

  30 months

Study Arms (1)

Observational

Observational study

Other: Observational

Interventions

Observational OTHER

HPTN 073 is an observational study in MSM in the United States

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-uninfected BMSM at risk for HIV infection in three U.S. cities. Enrollment will include those aged 18 and over with efforts at each site to attempt to recruit an equal number of BMSM under age 25 and 25 and over.

You may qualify if:

• years of age or older
• No prior HIV diagnosis (self-report)
• Male at birth
• High risk for acquiring HIV infection including any one of the following in the previous 6 months:
• Unprotected sex during receptive or insertive anal intercourse with a male partner
• Any protected or unprotected:
• i. Receptive or insertive anal intercourse with more than three male sex partners ii. Exchange of money, gifts, shelter or drugs for receptive or insertive anal sex with a male partner iii. Receptive or insertive anal sex while under the influence of drugs or alcohol (i.e., high or drunk within two hours of the sex act) according to self-report"
• STI diagnosis (i.e., syphilis, gonorrhea and chlamydia) by self-report
• Willing to provide locator information in accordance with the Study Specific Procedures (SSP) Manual
• Urine dipstick negative or trace for protein and glucose
• Hemoglobin \> 11 g/dL, absolute neutrophil count \> 750 cells/mm3, and platelet count ≥ 100,000/mm3
• Serum creatinine \< upper limit of normal (ULN) and calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula where:
• o eCcr in mL/min = \[(140 - age in years) x (actual body weight in kg)\] / (72 x serum creatinine in mg/dL) Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) \< 3 times the upper limit of normal (ULN)
• Total bilirubin \< 2.5 ULN
• Hepatitis B surface antigen (HBsAg) negative

You may not qualify if:

• BMSM who meet any of the following criteria will be excluded from this study:
• Any reactive or positive HIV test at Screening, even if subsequent testing indicates that the person is HIV-uninfected
• Transgender
• Active or chronic hepatitis B infection (as evidenced by HBsAg, HbsAb, and HbcAb testing)
• Planning to move out of the area or to travel for more than 3 months during the study follow-up period
• Unwilling to adhere to study procedures
• Use of ARV drugs (PrEP or PEP) in the last 60 days
• Prior history of a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption (provided by self-report, or obtained from medical history or records)
• Receipt of prohibited medications: interleukin therapy, medications with significant nephrotoxic potential (including but not limited to amphotericin B, aminoglycosides, cidofovir, foscarnet and systemic chemotherapy), and medications that may inhibit or compete for elimination via active renal tubular secretion (including but not limited to probenecid) - (provided by self-report, or obtained from medical history or medical records)
• Any condition, that in the opinion of study staff, would make participation in the study unsafe, or interfere with achieving the study objective

Sponsors & Collaborators

• HIV Prevention Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

UCLA Vine Street Clinic

Los Angeles, California, 90095, United States

Location

George Washington University CRS

Washington D.C., District of Columbia, 20007, United States

Location

UNC CRS

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• Hightow-Weidman LB, Magnus M, Beauchamp G, Hurt CB, Shoptaw S, Emel L, Piwowar-Manning E, Mayer KH, Nelson LE, Wilton L, Watkins P, Whitfield D, Fields SD, Wheeler D. Incidence and Correlates of Sexually Transmitted Infections Among Black Men Who Have Sex With Men Participating in the HIV Prevention Trials Network 073 Preexposure Prophylaxis Study. Clin Infect Dis. 2019 Oct 15;69(9):1597-1604. doi: 10.1093/cid/ciy1141.

  PMID: 30615169 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine specimens to be stored after the end of the study for possible future testing.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Steven Shoptaw, PhD

  UCLA Vice Street Clinic

  PRINCIPAL INVESTIGATOR

• Manya Magnus, PhD, MPH

  George Washington University CRS

  PRINCIPAL INVESTIGATOR

• Lisa Hightow-Weidman

  UNC CRS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 11, 2013
• Study Start: August 15, 2013
• Primary Completion: September 30, 2015
• Study Completion: September 30, 2015
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)